Z-1092-2009

GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system...

Name: Z-1092-2009 GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system...
Creator: GE Medical Systems, LLC
Published: 2008-03-06
License: https://open.fda.gov/license/

GE Healthcare / initiated 2008-03-06 / Terminated / root cause: software

FDA source

GE Medical Systems, LLC began a recall of GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane positioner, a vascular or... on 2008-03-06. The reason FDA records is "GE Healthcare reported an issue with the Exposure Switch Redundancy system with Innova Systems 3100 & 4100, in which this error stays on, even after the pedal is released, inhibiting further x-rays, and a system reset...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1092-2009
Status: Terminated
Initiated: 2008-03-06
Posted: 2009-03-12
Terminated: 2014-09-04
Recalling firm: GE Healthcare
Product: GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) Indicated for use in diagnostic and interventional angiographic procedures of human anatomy. Intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures. Not intended for mammography applications.
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Reason for recall: GE Healthcare reported an issue with the Exposure Switch Redundancy system with Innova Systems 3100 & 4100, in which this error stays on, even after the pedal is released, inhibiting further x-rays, and a system reset is required to recover.
Root cause tag: software
FDA root cause: Software design
Action: On site visits were performed from 3/6/08 - 12/19/08 to update software on all 5 units.
Quantity in commerce: 4
Distribution: Worldwide Distribution -- USA including states of MD, TX, and VA and country of China.
Product codes and lots: 82416120006, 4103323100, 82416120005, and 214324INNOVA2

Product code MQB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)